Single-Arm, Prospective, Multicenter Study Evaluating Safety, Tolerability, and Metabolism of Niraparib as Maintenance Following Front-Line Treatment for Ovarian Cancer in Women of African Ancestry
University of Miami
Summary
The purpose of this study is to identify the genetic characteristic(s), specifically degree of African ancestry, and environmental characteristic(s) that appear to be related to the effects, both good and bad, that the maintenance treatment has women with ovarian cancer. In this study, an investigational medication called niraparib is being tested for the treatment of ovarian cancer. Niraparib works by blocking the ability of cancer cells to fix their genes. Cancer cells with damaged genes have a harder time growing and spreading in the body and can even die.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must be female ≥18 years of age, able to understand study procedures, and agree to participate in the study by providing written informed consent. 2. Self-identify as Black. Please note that individuals who identify as Latino are eligible to participate so long as they also self-identify as Black. 3. Participant has completed adjuvant treatment for newly diagnosed stage III or IV ovarian, fallopian tube, or primary peritoneal cancer according to the International Federation of Gynecology and Obstetrics staging criteria. 4. Participant must have high-grade se…
Interventions
- DrugNiraparib
Niraparib will be administered orally (PO) daily as tablets at one of three possible dose levels, 100mg/day, 200mg/day or 300mg/day, based upon participant weight, platelet count, and certain drug combinations and conditions assessed at baseline.
Locations (3)
- Broward HealthFort Lauderdale, Florida
- University of MiamiMiami, Florida
- Ahmadu Bello University Teaching Hospital (ABUTH)Zaria, Kaduna State